InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System.

The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S.

“This is a key milestone in the history of our company as it helps pave the way for us to initiate a clinical trial of CGuard EPS for addressing Carotid Artery Disease and preventing stroke in the United States market. This will be the first U.S.-based study of CGuard which is a cornerstone of our global expansion plans,” CEO Marvin Slosman said in a news release. “A pivotal trial of this kind requires significant preparation and allocation of resources and we have already begun to move pieces into place in order to plan the initiation of our Carenet-III study. The FDA approval of the IDE represents an important step in enabling us to conduct a pivotal clinical trial to demonstrate the potential for CGuard EPS against carotid artery disease, which accounts for more than 6.2 million deaths worldwide, and a cost burden of more than $34 billion in the U.S. alone.”

The study will enroll 315 patients in up to 40 U.S. institutions. The company plans to announce additional details as it continues to plan the study.

InspireMD’s CGuard Embolic Protection System is designed to deliver the flexibility of traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that lead to stroke. The device can mitigate the prolapse and associated embolization and its new iteration allows for the protected treatment of carotid artery disease with the potential for managing the disease and stroke prevention.